This blog began in 2007, focusing on anthrax vaccine, and later expanded to other public health and political issues. The blog links to media reports, medical literature, official documents and other materials.

Tuesday, March 12, 2013

The NY Times ' Donald McNeil has followed up the juicy story of how billionaire political donor Ronald Perelman got a sweetheart contract (OMG, read David Willman's story and weep, that deal was so sweet) for a high-priced smallpox drug, which isn't actually needed cause we have enough vaccine for every American, and if you are vaccinated within about 4 days after exposure to smallpox, you won't get the disease, which has a 2-3 week incubation period.

Plus, the price is way too high. The drug is cheap to produce but cost the taxpayer an arm and a leg. Talk about golden toilet seats.

The new wild west of biodefense contracting can turn paupers into millionaiers. More commonly, however, it turns the extremely wealthy into the wealthiest. But you have to pay to play.

DHHS waited for the noise to die down, and has now finalized the contract.

By DONALD G. McNEIL Jr.
The United States government is buying enough of a new
smallpox medicine to treat two million people in the event of a bioterrorism
attack, and took delivery of the first shipment of it last week. But the
purchase has set off a debate about the lucrative contract, with some experts
saying the government is buying too much of the drug at too high a price.

A small company, Siga Technologies, developed the drug in
recent years. Whether the $463 million order is a boondoggle or bargain depends
on which expert is talking.

Smallpox was eradicated by 1980 and the only known remaining
virus is in government laboratories in the United States and Russia. But there
have long been rumors of renegade stocks that could be sprayed in airports or
sports stadiums. Experts say the virus could also be re-engineered into
existence in a sophisticated genetics lab.

As part of its efforts to prepare for a possible
bioterrorism attack, the government is paying over $200 for each course of
treatment.

Siga Technologies, which is controlled by the billionaire
takeover specialist Ronald O. Perelman, will show a profit for the first time
once the contract is paid for. It argues that the price is a fair return on
years of investment.

And Robin Robinson, director of the Biomedical Advanced
Research and Development Authority, part of the Department of Health and Human
Services, the overseer of the contract for the drug, Arestvyr, defended the
size of the order and the price paid. He said that

two million doses was the amount modelers predicted would be
needed to contain a smallpox outbreak in a large city and that the whole
country would require 12 million, along with vaccines.

The price, he said, was arrived at through federal
purchasing guidelines and was “fair and reasonable” compared with the price of
other commercial antiviral drugs, which he said ranged from $108 to $7,364.

But when stockpiling a smallpox drug was first proposed in
2001 after the Sept. 11 and anthrax attacks, it was expected to cost only $5 to
$10 per course, said Dr. Donald A. Henderson, who led a government advisory
panel on biodefense in the wake of those attacks. Dr. Henderson was a leader in
the eradication of smallpox in the 1960s and is now at the Center for
Biosecurity at the University of Pittsburgh Medical Center.

Dr. Richard H. Ebright, a bioweapons expert at Rutgers
University, said there was little need for so much of the drug, Arestvyr, since
the country has raised its stockpile of smallpox vaccine to 300 million doses
now, up from only 15 million in 2001.

“Is it appropriate to stockpile it? Absolutely,” he said.
“Is it appropriate to stockpile two million doses? Absolutely not. Twenty
thousand seems like the right number.”

Vaccines are normally given before an infection to prevent a
disease, while antivirals are given after virus infections, to treat them.
Smallpox has such a long incubation period that the vaccine can prevent disease
even if given as late as three days after infection. Arestvyr may also prevent
infection if given early enough, but that has not been proven.

Dr. Eric A. Rose, the president of Siga and a vice president
of Mr. Perelman’s holding company, MacAndrews & Forbes, acknowledged that
the drug cost little to make, but said the price being charged for a patented
drug was a bargain compared with AIDS antiretrovirals that cost $20,000 a year
and cancer drugs that cost over $100,000 a year.

Asked about the size of the purchase, he compared it with a
flu drug. “There are 80 million courses of Tamiflu in the strategic national
stockpile,” he said. “Smallpox is just as contagious and has 30 times the
mortality. By measures like that, I’d say 2 million is on the low end.”

He also said that Mr. Perelman had invested $80 million in
the company through years of research with no sales. Without a profit
potential, no company would take up smallpox, Ebola and other lethal but very
rare diseases, he said.

And Dr. Isaac B. Weisfuse, who was formerly head of pandemic
planning for the New York City Health Department and is now Siga’s medical
policy director, said that plans calling for tens of million Americans to be
vaccinated within days of a major smallpox outbreak were unrealistic and that
Arestvyr could save lives.

Arestvyr — which until November was known as ST-246 or
tecovirimat — prevents the virus from forming the double outer envelope that
lets it break out of the first cells it infects and spread throughout the body.
A 14-day course can be taken in combination with smallpox vaccine, offering
double protection, which Dr. Henderson called “quite amazing.”

Arestvyr is not approved by the Food and Drug Administration
except for use in emergencies.

It has never been tested on smallpox in humans because the
disease was eradicated. However, it has prevented death in dozens of monkeys
injected with what would normally have been lethal doses of smallpox or a
related virus, monkey pox.

It also appears to have helped several humans suffering from
potentially lethal reactions to smallpox vaccine, which is itself a live
smallpox-related virus, but normally harmless. They included a child near death
after catching his father’s vaccination virus, a soldier vaccinated just before
discovering he had leukemia, and a woman whose immune system was suppressed by
steroids and who was infected by touching bait meant for raccoons that
contained a combined rabies/smallpox vaccine.

However, those patients were also given immune globulin,
other drugs and hospital care, so it is hard to know exactly what worked.

Bioterrorism experts say the need for Arestvyr has declined
since the United States increased its stockpile of smallpox vaccine, including
a less potent but less risky backup vaccine for those who cannot tolerate the
standard one.

The word “smallpox” still strikes fear. John Grabenstein , a
retired colonel and top biodefense adviser to the Defense Department after the
2001 attacks, recalled reports of refrigerated Soviet warheads loaded with the
virus that could, in theory, aerosolize it over large areas. Others have
envisioned a few infected terrorists mingling in crowds.

Left untreated, smallpox kills a third of victims. But
prominent experts say the danger is overblown. Because it can take up to two
weeks before an infected person becomes seriously ill, and up to five more days
before he begins to infect others, there is time to respond, they said.

Also, they said, by the time smallpox victims reach the
infectious stage, when their pox are erupting, they are too sick to wander
around. That is why outbreaks in schools or factories were nearly unheard-of

Smallpox was eradicated by “ring vaccination” — finding each
case and vaccinating just the 50 to 200 people closest to it.

“If we had to, we could vaccinate the entire country in
three days,” said Dr. William H. Foege, another leader of the smallpox
eradication effort who now advises the Bill & Melinda Gates Foundation.
This vaccine does not use a syringe, but a forked pin that Dr. Foege said he
could “train anyone to use in 10 minutes.” In a true emergency, he argued,
schoolteachers, police officers, firefighters and others would all be
vaccinators.

Other experts think that is overoptimistic, since an attack
would cause panic.

Also, Dr. Rose of Siga pointed out, there are only an
estimated 700 million doses of smallpox vaccine in a world of 7 billion people,
so the United States might use its vaccine and Arestvyr stockpile to help other
countries. (Only the United States, Japan and Israel are believed to have
enough doses for their entire populations, experts said.)

Dr. Henderson and Dr. Philip Russell, who formerly headed
the Walter Reed Army Institute of Research and served on the advisory panel
with him, said they expected the government to pay much less for an antiviral
drug since they cost little to make and the alternative, vaccines, cost the
government $3 a dose. “If they’re talking $250 a course, they’re a bunch of
thieves,” Dr. Russell said.

Other experts, like Dr. Grabenstein , said that since the
drugs have no other use, they are like aircraft carriers: to entice companies
to make them, the government has to pay all the costs plus guarantee the
producer a profit — and that it might be prudent to have extras on hand.

Mr. Perelman’s company, MacAndrews & Forbes, has spent
more than $1 million lobbying each year since 2008, according to the Center for
Responsive Politics, a watchdog group. A spokeswoman for the company, Christine
Taylor, said it had done “absolutely no lobbying” for the Siga contract.

After swimming with dolphins at Key Largo, they checked me out at the edge of the pool

Visiting a Bhutanese Dzong, the regional seat of both government and religion (and a fort for good measure)

Why am I blogging?

Because life is meant to be lived! The left side of this blog has photos of some peak experiences. And the right side contains information about which I am passionate.

Too many peoples' lives are characterized by lack of authenticity, and fear of acknowledging and expressing their true nature. Employees cannot say what they think at work, and in the corporate system we must squish ourselves into square holes when we are round pegs. We thus lose touch with our souls, becoming cogs in a soulless, profit-driven machine.

The culture of political correctness has meant, in medicine, that we ignore how the foundations of our science are being undermined by commercialism. Clinical data generated or presented by the manufacturers of drugs, vaccines and devices cannot be trusted: there are hundreds of studies proving this. But this fraudulent information continues to be the only data informing the approval of vaccines, drugs and devices.

Unless scrupulous ethical conduct is demanded of physicians and biological scientists, our lack of meaningful standards will carry the medical-pharmaceutical system down the path of increasing irrelevance.

Medicine and its tools need to be affordable. The current medical-industrial milieu, characterized by contempt for science, countless ways for insiders to achieve wealth due to failure of good governance, and regulatory agency-to-industry revolving doors, has ushered in stratospheric pricing... further kicking us down that path to irrelevance.

Why is our new health care plan a giveaway to health industries instead of to health consumers? Why won't it cover all Americans? Why was the "public option" never an option for the Obama administration? Why did the promised Trump health plan evaporate the moment he was elected?

So many of our leaders carry a heavy burden of mendacity and avarice. If they instead got in touch with their own souls (perhaps by exposure to the natural world), or made their decisions by maximizing the amount of good that results, our leaders might find real meaning and value in their lives.

Until that happens, the only way to straighten out the current mess is to demand accountability and impose penalties on unethical/dishonest leaders. Both political parties enjoy bounteous hors d'oeuvres from Pharma's table, making it unlikely the existing political "process" will provide relief--as we've seen in the demoralizing healthcare reform drama.

Until then, I'll continue to "call it as I see it" in this blog -- working and living the way life should be, in rural Maine, far from the centers of power.

Ellen Byrne has created several designs encapsulating aspects of the FBI's ridiculous case against Bruce Ivins. They can be purchased on T-shirts and coffee mugs. All proceeds will be donated to the the Frederick County chapter of the American Red Cross, a favored charity of Dr. Bruce Ivins.